It is desirable that a product for general douching purposes have an effective cleansing action on the vaginal surfaces, that it be mildly astringent, and that it have an acidity approximating that of the normal vagina, i.e., a pH between 3.0 and 6.0, and preferably between 4.0 to 5.0. The douche must not interfere with the natural reaction of the vaginal tract or disturb the development of a normal bacterial flora which is generally cosidered essential to the maintenance of a healthy condition.
Hence, it is important that the douche be capable of establishing and maintaining the desired acidity. Further, it is important that the douche solution be free from components which would destroy certain bacilli which are normally and desirably present in the vagina. It is also desirable in the case of a solution that is to come in contact with a permeable membrane such as that of the vaginal surface, that the solution be approximately isotonic or perhaps somewhat hypertonic so that the solution has a balanced electrolyte concentration equivalent to or somewhat greater than that of the normal body electrolyte composition. Furthermore, the ingredients should be non-toxic and free from irritating and other deleterious properties, and be chemically and physically stable so that the composition may be stored over a relatively long period of time without deteriorating.
It is extremely important that the proper types, combinations, and concentrations of multiple electrolytes be used in this invention, since it is well established in basic tissue culture studies that living cells survive better and are more healthy in an isotonic, multiple electrolyte composition than in simple isotonic saline (sodium chloride).
It is equally desirable to have an effective solution for the external cleansing of the vulva. The external cleansing solution (i.e. the wipe) should contain an anti-bacterial, anti-inflammatory, and anti-allergic agent for effectively cleansing and relieving irritation of the vagina. The wipe solution should also have a pH similar to that of the vagina, approximately 3.5 to 4.5. As in the case of douche solutions, the external wipe should also be non-toxic and free from irritants, and be chemically and physically stable so that the material may be stored without deteriorating. It is further desirable to use the wipe solution in conjunction with the douche solution in order to cleanse the entire vaginal area.
The relevant prior art includes U.S. Pat. No. 3,219,525, which discloses the use of combinations of lactic, citric or acetic acid with sodium bicarbonate, sodium lactate, sodium citrate or sodium acetate to obtain a suitable pH for a douche product employing one or more quaternary detergents.
U.S. Pat. No. 2,649,398 discloses the use of citric acid in a douche, and also discloses the desirability of having an isotonic concentration of sodium chloride in a detergent solution.
U.S. Pat. No. 2,556,567, also discloses a douche solution with an isotonic concentration of sodium chloride in a detergent solution.
U.S. Pat. No. 3,346,450 discloses the desirability of having a douche with a pH of 3.5 to 5.0.
U.S. Pat. No. 4,568,540 discloses the use of sodium gluconate as a buffering agent to maintain a pH of 3.5 to 6.0 in an oral hygiene composition.
U.S. Pat. No. 4,581,226 discloses the use of diluted sterilized seawater for treating sensitive animal tissue. The seawater is diluted to make it isotonic with the tissue to be treated. This patent also mentions use of this seawater solution as a vaginal douche, but the solution disclosed therein is not a balanced electrolyte medium; i.e. it has a different electrolyte composition from human tissue.
U.S. Pat. No. 4,556,557, discloses the use of sorbic acid as a preservative in a product used for treating the nasal mucosa.
An article entitled "Methods of Use of Waters with High Sodium Chloride Content," Presse Therm. Clim., 112/1, 15-16 (1975) (in French) discloses the use of a mineral water douche. In addition to NaCl, the solution also contains potassium chloride and magnesium chloride.
Other relevant articles include "Salt Therapy," Therapiewoche, 30/40, 6564-6571 (1980) (in German) which discloses the use of brine douches; Therapiewoche, 31/29 4726-4729 (1981) (in German) which discloses the use of natural water for douching; and "Contact Dermatitis," Cutis, 8, 341-342 (1982) discloses that sorbic acid is a suitable preservative for use in products for treatment of the oral mucosa.
Normosol solution (trademark of Abbott Laboratories), is a product use intravenously in hospitals as an irrigation solution and electrolyte replenisher. Normosol formulas are sterile, non-pyrogenic solutions of balanced electrolytes in water for injection. The solutions contain no bacteriostat, anti-microbial agent or added buffer (except for pH adjustment).
The present invention incorporates Normosol solution, but uses citric acid to adjust pH instead of hydrochloric acid. Normosol solution has a pH of 6.4, whereas the final pH of the present invention ranges from 3.5 to about 4.5. The normal vagina has a pH range of 3.0 to 6.0. Usually, the pH of the vagina falls between 4.0 and 5.0. The pH of Normosol solution is well above the pH of the normal vagina, and hence it would be ineffective as a vaginal cleansing agent. Thus, the substitution of citric acid in place of hydrochloric acid creates a novel composition which is effective for douching. It should also be noted that Normosol solution, being sterile, does not have sorbic acid as a preservative.
There are several topical anti-infective, antiseptic solutions used to soothe and heal mild skin abrasions and irritations. One such product is Lady Protex, from National Sanitary Laboratories, comprising: benzalkonium chloride, octoxynol 9, water, propylene glycol, menthol, propyl paraben, citric acid, and fragrance. Another product is Bidette from Young Drug Products, comprising: water, ethyl alcohol, polysorbate 20, benzalkonium chloride, menthol, sodium bicarbonate, and fragrance.
Although the prior art thus exhibits a variety of relatively safe and reliable douching and topical anti-infective formulations, there are problems with the compositions and effectiveness of these existing formulations.
First, the douche products disclosed, with the exception of seawaterm, contain detergents. The more common douching detergents include dioctyl sodium sulfosuccinate, nonoxynol, octoxynol, and sodium lauryl sulfate. These detergents are among the few ingredients endorsed by the FDA and the OTC panel as acceptable for use in non-prescription douche products. Thus, douche solution alternatives are limited. The seawater solution alone (disclosed in U.S. Pat. No. 4,581,226), without the addition of various amino acids and substrates, is not a balanced electrolyte solution as is the invention herein.
Second, the detergents used in the existing douche products may also cause vaginal irritation due to differences between the douche solutions and the natural vaginal physiological fluids.
Third, although the prior art discloses the desirability of douche solutions with suitable pH's and isotonic concentrations, no solution to date achieves that result with balanced electrolytes for optimal tissue safety and also uses nothing but natural ingredients in an electrolyte solution.
Fourth, the products that are applied topically differ in their composition and mode of application. The invention herein is applied to the external vulva by an anti-bacterial saturated towelette.
Fifth, the existing douche products require precise mixing before use and are limited to internal cleansing of the vagina. There is no prior art that discloses a disposable hygiene system that is suitable for both internal vaginal and external vulval cleansing.